Stellate Ganglion Block to Reduce Hot Flushes

NCT ID: NCT03756272

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-02-01

Brief Summary

To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure

Detailed Description

Hot flushes are the most common symptom of menopause for which postmenopausal (PMP) women seek medical help, in 20% of PMP women hot flushes can persist for up to 15 years.

A possible treatment for hot flushes is stellate ganglion block (SGB), used as a means to interrupt parts of the sympathetic nervous system involved in temperature regulation.

Single centre randomized double blind placebo controlled intervention study Study period of 6 months in which patients will fill out on set time points 5 questionnaires regarding quality of life and keep a diary on hot flush frequency and severity during1 week on the same time points.

Study population:

Postmenopausal women aged 30-70 years old with no other causes of flushing present. Intervention (if applicable) Intervention: Stellate ganglion block versus sham procedure

Follow up with questionnaires during 6 months.

Conditions

Hot Flash; Stellate Ganglion Block; Postmenopausal; Hot Flushes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Stellate ganglion bupivacaine block

Nervus Sympathicus block. Stellate ganglion anaesthetic block in which 7 ml of 0.5% bupivacaine will be injected next to the stellate ganglion

Group Type: EXPERIMENTAL

Bupivacaine block

Intervention Type: PROCEDURE

stellate ganglion bupivacaine injection

Placebo ganglion block

Sham Nervus Sympathicus block. Stellate ganglion sham anaesthetic block using 7 ml of 0.9 % natrium chloride (NaCl)

Group Type: PLACEBO_COMPARATOR

Placebo ganglion block

Intervention Type: PROCEDURE

stellate ganglion sodium chloride injection

Interventions

Bupivacaine block

stellate ganglion bupivacaine injection

Intervention Type: PROCEDURE

Placebo ganglion block

stellate ganglion sodium chloride injection

Intervention Type: PROCEDURE

Other Intervention Names

Stellate ganglion Block; stellate ganglion natrium chloride 0.9% injection

Eligibility Criteria

Inclusion Criteria

• Female
• Age: 30-70 years
• Mean daily flush frequency of 10 or more and a hot flush score of 15 or more
• Absence of any non-menopausal cause of flushing
• Post-menopause amenorrhea for more than 1 year in healthy postmenopausal women
• In case of breast cancer or ovariectomy induced menopause: ovariectomy for > 6 months. Adjuvant therapy with estrogen-receptor blocker or an aromatase inhibitor.

Exclusion Criteria

• Use of medication that affects flushing:oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlafaxine, gabapentin, luteïniserend hormone releasing hormones receptor antagonist
• Receiving chemotherapy of radiotherapy
• Active psychiatric disease
• Active concurrent disease
• Allergic reactions against local anesthetics of the 'amide' type or contrast media.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Willem Kallewaard, MD

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital

Locations

Rijnstate hospital

Arnhem, , Netherlands

Countries

Netherlands

Other Identifiers

NL54465.091.15

Identifier Type: -

Identifier Source: org_study_id